All sections
FDA clearances of healthcare AI, one table
Every 510(k), De Novo and PMA decision cited in our tool reviews, with the FDA number, the decision date and a link to the FDA record. A clearance covers a specific device and indication, not the vendor, so the device column matters as much as the number.
How to read this index
510(k) means the FDA found the device substantially equivalent to one already on the market. De Novo is the route for a new kind of low-to-moderate risk device, so a De Novo number (7 here) usually marks the first product of its type. PMA is the full premarket approval for high-risk devices. The numbers come from the research behind each review and are checked against the FDA database; the FDA record is the source of truth, and each number links to it.
Tools without any FDA decision are not listed. That includes most scribes, coding tools and reference products, which do not need clearance, and vendors that sell only outside the United States. A missing row is not a judgment on the product.
Decision support
| Tool | Device on the FDA record | FDA number | Pathway | Decision |
|---|---|---|---|---|
| Bayesian Health Sepsis Flagging Device | K250680 | 510(k) | Apr 30, 2026 |
Radiology
| Tool | Device on the FDA record | FDA number | Pathway | Decision |
|---|---|---|---|---|
Elucid Elucid Bioimaging | Elucid PlaqueIQ | K261855 | 510(k) | Sep 18, 2026 |
| Elucid | Elucid PlaqueIQ | K241524 | 510(k) | Sep 12, 2024 |
| qCT Lung v1.0 | K261517 | 510(k) | Sep 14, 2026 | |
| Qure.ai | qXR-Detect | K251934 | 510(k) | Jan 16, 2026 |
| Qure.ai | qER-CTA v1.0 | K251610 | 510(k) | Sep 8, 2025 |
| Qure.ai | qCT LN Quant | K240740 | 510(k) | Aug 16, 2024 |
| Qure.ai | qXR-LN | K231805 | 510(k) | Dec 22, 2023 |
| Qure.ai | qXR-CTR | K231149 | 510(k) | Sep 22, 2023 |
| Qure.ai | qXR-PTX-PE | K230899 | 510(k) | Aug 22, 2023 |
| Qure.ai | qXR-BT | K212690 | 510(k) | Dec 21, 2021 |
| Qure.ai | qER-Quant | K211222 | 510(k) | Jul 30, 2021 |
| Qure.ai | qER | K200921 | 510(k) | Jun 17, 2020 |
DeepHealth RadNet / DeepHealth, Inc. | ChestView US 1.1 (Gleamer) | K252486 | 510(k) | Sep 9, 2026 |
| DeepHealth | Saige-Dx | K253825 | 510(k) | Jun 15, 2026 |
| DeepHealth | Breast arterial calcification (BAC) software | K254131 | 510(k) | May 21, 2026 |
| DeepHealth | Saige-Dx | K251873 | 510(k) | Aug 11, 2025 |
| DeepHealth | TechLive | K243703 | 510(k) | Jun 5, 2025 |
| DeepHealth | ChestView US (Gleamer) | K241620 | 510(k) | Feb 27, 2025 |
| DeepHealth | BoneMetrics (Gleamer) | K241593 | 510(k) | Feb 5, 2025 |
| DeepHealth | Saige-Dx 3.1.0 | K243688 | 510(k) | Dec 19, 2024 |
| DeepHealth | Saige-Density 2.5.0 | K243705 | 510(k) | Dec 19, 2024 |
| DeepHealth | Saige-Dx | K241747 | 510(k) | Nov 18, 2024 |
| DeepHealth | ProFound Detection V4.0 (iCAD) | K240417 | 510(k) | Nov 8, 2024 |
| DeepHealth | BoneView (Gleamer) | K222176 | 510(k) | Mar 2, 2023 |
| DeepHealth | Saige-Density | K222275 | 510(k) | Dec 16, 2022 |
| DeepHealth | Saige-Dx | K220105 | 510(k) | May 12, 2022 |
| DeepHealth | BoneView (Gleamer) | K212365 | 510(k) | Mar 1, 2022 |
| DeepHealth | Saige-Q (triage) | K203517 | 510(k) | Apr 16, 2021 |
| DeepHealth | ProFound AI V3.0 (iCAD) | K203822 | 510(k) | Mar 12, 2021 |
| DeepHealth | ProFound AI V2.1 (iCAD) | K191994 | 510(k) | Oct 4, 2019 |
AZmed Rayvolve AZmed | Rayvolve AZchest | K261378 | 510(k) | Aug 28, 2026 |
| AZmed Rayvolve | Rayvolve | K260378 | 510(k) | May 12, 2026 |
| AZmed Rayvolve | Rayvolve LN | K243831 | 510(k) | Mar 26, 2025 |
| AZmed Rayvolve | Rayvolve PTX-PE | K243808 | 510(k) | Mar 21, 2025 |
| AZmed Rayvolve | Rayvolve | K240845 | 510(k) | Jul 17, 2024 |
| AZmed Rayvolve | Rayvolve | K220164 | 510(k) | Jun 2, 2022 |
Hyperfine Swoop Hyperfine | Swoop | K262622 | 510(k) | Aug 19, 2026 |
| Hyperfine Swoop | Swoop | K253489 | 510(k) | Dec 12, 2025 |
| Hyperfine Swoop | Swoop (V2) | K250236 | 510(k) | May 30, 2025 |
| Hyperfine Swoop | Swoop | K251276 | 510(k) | May 21, 2025 |
| Hyperfine Swoop | Swoop | K240944 | 510(k) | Jul 16, 2024 |
| Hyperfine Swoop | Swoop | K232760 | 510(k) | Oct 6, 2023 |
| Hyperfine Swoop | Swoop | K230208 | 510(k) | Feb 22, 2023 |
| Hyperfine Swoop | BrainInsight | K223268 | 510(k) | Dec 16, 2022 |
| Hyperfine Swoop | Swoop | K223247 | 510(k) | Dec 6, 2022 |
| Hyperfine Swoop | Swoop | K221923 | 510(k) | Jul 28, 2022 |
| Hyperfine Swoop | BrainInsight | K220815 | 510(k) | Jul 19, 2022 |
| Hyperfine Swoop | Swoop | K221393 | 510(k) | Jun 10, 2022 |
| Hyperfine Swoop | Swoop | K212456 | 510(k) | Nov 17, 2021 |
| Hyperfine Swoop | Swoop | K211818 | 510(k) | Jul 7, 2021 |
| Hyperfine Swoop | BrainInsight | K202414 | 510(k) | Jan 7, 2021 |
| Hyperfine Swoop | Hyperfine POC MRI | K201722 | 510(k) | Aug 11, 2020 |
| Hyperfine Swoop | Lucy POC MRI | K192002 | 510(k) | Feb 6, 2020 |
ScreenPoint Transpara ScreenPoint Medical | Transpara (2.1.0) | K260898 | 510(k) | Aug 14, 2026 |
| ScreenPoint Transpara | Transpara (2.1.0) | K241831 | 510(k) | Nov 25, 2024 |
| ScreenPoint Transpara | Transpara Density 1.0.0 | K232096 | 510(k) | Dec 11, 2023 |
| ScreenPoint Transpara | Transpara 1.7.2 | K221347 | 510(k) | Aug 3, 2022 |
| ScreenPoint Transpara | Transpara 1.7.0 | K210404 | 510(k) | Jun 2, 2021 |
| ScreenPoint Transpara | Transpara | K193229 | 510(k) | Mar 5, 2020 |
| ScreenPoint Transpara | Transpara | K192287 | 510(k) | Dec 10, 2019 |
| ScreenPoint Transpara | Transpara | K181704 | 510(k) | Nov 21, 2018 |
| cmAngio V2.0 | K260980 | 510(k) | Jul 30, 2026 | |
| CureMetrix | cmAngio V1.6 | K250754 | 510(k) | Apr 10, 2025 |
| CureMetrix | cmAngio V1.0 | K232367 | 510(k) | Oct 5, 2023 |
| CureMetrix | cmTriage | K183285 | 510(k) | Mar 8, 2019 |
| Cleerly LABS | K260588 | 510(k) | Jul 29, 2026 | |
| Cleerly | Cleerly Plaque | K261210 | 510(k) | Jul 29, 2026 |
| Cleerly | Cleerly LABS (v2.0) | K242338 | 510(k) | Mar 7, 2025 |
| Cleerly | Cleerly ISCHEMIA | K231335 | 510(k) | Sep 8, 2023 |
| Cleerly | Cleerly Labs v2.0 | K202280 | 510(k) | Oct 2, 2020 |
| Cleerly | Cleerly Labs | K190868 | 510(k) | Nov 5, 2019 |
Caristo Diagnostics Caristo | CaRi-Heart | DEN250042 | De Novo | Jul 28, 2026 |
| Caristo Diagnostics | CaRi-Plaque | K242240 | 510(k) | Feb 20, 2025 |
| Caristo Diagnostics | CariCloud | K200274 | 510(k) | May 21, 2020 |
Therapixel MammoScreen Therapixel | MammoScreen (5) | K260714 | 510(k) | Jun 26, 2026 |
| Therapixel MammoScreen | MammoScreen BD | K243685 | 510(k) | Aug 22, 2025 |
| Therapixel MammoScreen | MammoScreen (4) | K243679 | 510(k) | Jul 3, 2025 |
| Therapixel MammoScreen | MammoScreen BD | K241561 | 510(k) | Oct 2, 2024 |
| Therapixel MammoScreen | MammoScreen (3) | K240301 | 510(k) | Aug 1, 2024 |
| Therapixel MammoScreen | MammoScreen 2.0 | K211541 | 510(k) | Nov 26, 2021 |
| Therapixel MammoScreen | MammoScreen | K192854 | 510(k) | Mar 25, 2020 |
| SubtleHD-CT 1.x | K254120 | 510(k) | May 15, 2026 | |
| Subtle Medical | SubtleHD-PET 1.x | K254013 | 510(k) | May 14, 2026 |
| Subtle Medical | SubtleHD 1.x | K243250 | 510(k) | Feb 12, 2025 |
| Subtle Medical | AiMIFY 1.x | K240290 | 510(k) | Aug 21, 2024 |
| Subtle Medical | SubtleSYNTH 1.x | K241329 | 510(k) | Jul 11, 2024 |
| Subtle Medical | SubtleREFORMAT 1.x | K233699 | 510(k) | Apr 29, 2024 |
| Subtle Medical | SubtleMR 2.3.x | K223623 | 510(k) | May 11, 2023 |
| Subtle Medical | SubtlePET | K211964 | 510(k) | Sep 28, 2021 |
| Subtle Medical | SubtleMR | K203182 | 510(k) | Feb 26, 2021 |
| Subtle Medical | SubtleMR | K191688 | 510(k) | Sep 16, 2019 |
| Subtle Medical | SubtlePET | K182336 | 510(k) | Nov 30, 2018 |
| Not named in our record | K261317 | 510(k) | May 14, 2026 | |
| Aidoc | CARE Multi-Triage CT | K253578 | 510(k) | Feb 26, 2026 |
| Aidoc | Not named in our record | K251195 | 510(k) | Jan 27, 2026 |
| Aidoc | BriefCase-Triage: CARE Multi-triage CT Body | K252970 | 510(k) | Jan 7, 2026 |
| Aidoc | Not named in our record | K253265 | 510(k) | Nov 6, 2025 |
| Aidoc | Not named in our record | K251406 | 510(k) | May 30, 2025 |
| Aidoc | Not named in our record | K250248 | 510(k) | Feb 14, 2025 |
| Aidoc | Not named in our record | K243548 | 510(k) | Dec 11, 2024 |
| Aidoc | Not named in our record | K242203 | 510(k) | Nov 22, 2024 |
| Aidoc | Not named in our record | K242837 | 510(k) | Oct 18, 2024 |
| Aidoc | Not named in our record | K241727 | 510(k) | Jul 12, 2024 |
| Aidoc | Not named in our record | K241112 | 510(k) | May 15, 2024 |
| Aidoc | Quantification | K231631 | 510(k) | Nov 28, 2023 |
| Aidoc | Not named in our record | K232083 | 510(k) | Nov 13, 2023 |
| Aidoc | Not named in our record | K230534 | 510(k) | Nov 8, 2023 |
| Aidoc | BriefCase-Triage | K232751 | 510(k) | Oct 30, 2023 |
| Aidoc | Not named in our record | K230020 | 510(k) | Feb 1, 2023 |
| Aidoc | Not named in our record | K222692 | 510(k) | Dec 5, 2022 |
| Aidoc | Not named in our record | K221330 | 510(k) | Nov 18, 2022 |
| Aidoc | Not named in our record | K220709 | 510(k) | Oct 7, 2022 |
| Aidoc | Not named in our record | K222329 | 510(k) | Sep 28, 2022 |
| Aidoc | Not named in our record | K222277 | 510(k) | Aug 26, 2022 |
| Aidoc | Not named in our record | K221314 | 510(k) | Jun 3, 2022 |
| Aidoc | Not named in our record | K221240 | 510(k) | May 17, 2022 |
| Aidoc | Not named in our record | K213886 | 510(k) | Apr 26, 2022 |
| Aidoc | Not named in our record | K213721 | 510(k) | Mar 21, 2022 |
| Aidoc | Not named in our record | K214043 | 510(k) | Mar 14, 2022 |
| Aidoc | BriefCase RibFx | K202992 | 510(k) | Apr 14, 2021 |
| Aidoc | Not named in our record | K203508 | 510(k) | Dec 29, 2020 |
| Aidoc | Not named in our record | K201020 | 510(k) | Aug 26, 2020 |
| Aidoc | Not named in our record | K193298 | 510(k) | Jun 19, 2020 |
| Aidoc | Not named in our record | K192383 | 510(k) | Dec 20, 2019 |
| Aidoc | Not named in our record | K190896 | 510(k) | May 31, 2019 |
| Aidoc | Not named in our record | K190072 | 510(k) | Apr 15, 2019 |
| Aidoc | BriefCase | K180647 | 510(k) | Aug 1, 2018 |
| Lunit INSIGHT MMG (v1.1.10) | K260320 | 510(k) | Apr 23, 2026 | |
| Lunit | Lunit INSIGHT DBT (V1.2) | K253796 | 510(k) | Mar 26, 2026 |
| Lunit | Lunit INSIGHT DBT v1.1 | K242652 | 510(k) | Oct 4, 2024 |
| Lunit | Lunit INSIGHT DBT | K231470 | 510(k) | Nov 6, 2023 |
| Lunit | Lunit INSIGHT MMG | K211678 | 510(k) | Nov 17, 2021 |
| Lunit | Lunit INSIGHT CXR Triage | K211733 | 510(k) | Nov 10, 2021 |
| Lunit | Volpara Imaging Software | K211279 | 510(k) | Jul 27, 2021 |
| Lunit | Volpara Imaging Software | K182310 | 510(k) | Sep 21, 2018 |
Siemens Healthineers AI-Rad Companion Siemens Healthineers | AI-Rad Companion Organs RT, update | K252548 | 510(k) | Apr 10, 2026 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Prostate MR, update | K252608 | 510(k) | Sep 9, 2025 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Organs RT, update | K242745 | 510(k) | Mar 27, 2025 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Organs RT, update | K232899 | 510(k) | Apr 3, 2024 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion (Cardiovascular), update | K222360 | 510(k) | Apr 6, 2023 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion (Musculoskeletal) | K222361 | 510(k) | Oct 20, 2022 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Brain MR, update | K213706 | 510(k) | Apr 15, 2022 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Organs RT | K193562 | 510(k) | Nov 6, 2020 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Prostate MR | K193283 | 510(k) | Jul 30, 2020 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion Brain MR | K193290 | 510(k) | Jun 17, 2020 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion (Cardiovascular) | K183268 | 510(k) | Sep 10, 2019 |
| Siemens Healthineers AI-Rad Companion | AI-Rad Companion (Pulmonary) | K183271 | 510(k) | Jul 26, 2019 |
| Siemens Healthineers AI-Rad Companion | AI Rad Companion (Engine) | K183272 | 510(k) | Feb 1, 2019 |
Canon Medical AI Canon Medical Systems | Vantage Fortian/Orian 1.5T V10.0 with AiCE | K253625 | 510(k) | Mar 27, 2026 |
| Canon Medical AI | Vantage Fortian/Orian 1.5T V10.0 with AiCE | K250901 | 510(k) | Jul 22, 2025 |
| Canon Medical AI | Vantage Galan 3T V10.0 with AiCE | K243335 | 510(k) | Jan 7, 2025 |
| Canon Medical AI | Vantage Galan 3T V10.0 with AiCE | K241496 | 510(k) | Aug 20, 2024 |
| Canon Medical AI | Vantage Fortian/Orian 1.5T V9.0 with AiCE | K240238 | 510(k) | Apr 12, 2024 |
| Canon Medical AI | Vantage Galan 3T V9.0 with AiCE | K230355 | 510(k) | Aug 30, 2023 |
| Canon Medical AI | Aquilion Precision V10.14 with AiCE | K223726 | 510(k) | Mar 7, 2023 |
| Canon Medical AI | Aquilion Serve V1.2 with AiCE-i | K222819 | 510(k) | Mar 3, 2023 |
| Canon Medical AI | Vantage Fortian/Orian 1.5T V8.0 with AiCE | K222968 | 510(k) | Oct 25, 2022 |
| Canon Medical AI | Aquilion Precision V10.10 with AiCE | K220986 | 510(k) | Sep 12, 2022 |
| Canon Medical AI | Vantage Galan 3T V8.0 with AiCE | K222387 | 510(k) | Aug 31, 2022 |
| Canon Medical AI | Vantage Galan 3T V8.0 with AiCE | K220192 | 510(k) | Apr 8, 2022 |
| Canon Medical AI | Vantage Fortian/Orian 1.5T V8.0 with AiCE | K220335 | 510(k) | Apr 5, 2022 |
| Canon Medical AI | Vantage Fortian 1.5T V8.0 with AiCE | K213305 | 510(k) | Dec 1, 2021 |
| Canon Medical AI | Vantage Galan 3T V7.0 with AiCE | K212056 | 510(k) | Aug 4, 2021 |
Philips Imaging AI Philips | Spectral CT Verida Family | K253649 | 510(k) | Mar 27, 2026 |
| Philips Imaging AI | EchoNavigator R5.0 | K253614 | 510(k) | Mar 17, 2026 |
| Philips Imaging AI | AV Cardiac CT | K260169 | 510(k) | Mar 5, 2026 |
| Philips Imaging AI | AV Vascular | K253735 | 510(k) | Jan 22, 2026 |
| Philips Imaging AI | LVivo Software Application (DiA Imaging Analysis) | K243862 | 510(k) | Mar 17, 2025 |
| Philips Imaging AI | LVivo Seamless (DiA Imaging Analysis) | K243331 | 510(k) | Mar 6, 2025 |
| Philips Imaging AI | Ultrasound Workspace (UWS 6.0) | K241659 | 510(k) | Feb 10, 2025 |
| Philips Imaging AI | Radiography 7300 C | K233662 | 510(k) | Jun 13, 2024 |
| Philips Imaging AI | LVivo IQS (DiA Imaging Analysis) | K240769 | 510(k) | May 24, 2024 |
| Philips Imaging AI | MRCAT Head and Neck | K214081 | 510(k) | Apr 5, 2022 |
| Philips Imaging AI | Precise Image | K210760 | 510(k) | Jan 14, 2022 |
| Philips Imaging AI | TOMTEC-ARENA (TomTec) | K213544 | 510(k) | Jan 6, 2022 |
| Philips Imaging AI | Precise Position | K203514 | 510(k) | Jun 17, 2021 |
| Philips Imaging AI | QLAB Advanced Quantification Software | K200974 | 510(k) | Jun 3, 2020 |
| Bunkerhill Contrast AVC | K260167 | 510(k) | Mar 6, 2026 | |
| Bunkerhill Health | Bunkerhill Contrast CAC | K260166 | 510(k) | Mar 6, 2026 |
| Bunkerhill Health | Bunkerhill MAC | K250662 | 510(k) | Oct 3, 2025 |
| Bunkerhill Health | Bunkerhill ECG-EF | K250649 | 510(k) | Sep 19, 2025 |
| Bunkerhill Health | Bunkerhill Abdominal Aortic Quantification (AAQ) | K243779 | 510(k) | Jul 1, 2025 |
| Bunkerhill Health | BunkerHill BMD | K242295 | 510(k) | Apr 8, 2025 |
| Bunkerhill Health | Bunkerhill AVC | K243229 | 510(k) | Jan 27, 2025 |
| Bunkerhill Health | CAC (gated) Algorithm | K240369 | 510(k) | Sep 27, 2024 |
| Bunkerhill Health | iCAC Device | K230223 | 510(k) | Apr 25, 2023 |
| Annalise Enterprise (applicant Harrison-AI Medical Pty, Ltd.) | K253818 | 510(k) | Mar 3, 2026 | |
| Harrison.ai | Annalise Enterprise | K250831 | 510(k) | Apr 23, 2025 |
| Harrison.ai | CTB Triage Trauma | K231767 | 510(k) | Sep 22, 2023 |
| Harrison.ai | CTB Triage Trauma | K231384 | 510(k) | Sep 22, 2023 |
| Harrison.ai | CTB Triage-OH | K231094 | 510(k) | Aug 15, 2023 |
| Harrison.ai | CTB Triage Trauma | K223240 | 510(k) | Apr 3, 2023 |
| Harrison.ai | CXR Triage Trauma | K222268 | 510(k) | Mar 28, 2023 |
| Harrison.ai | CXR Triage Trauma | K222179 | 510(k) | Mar 28, 2023 |
| Harrison.ai | CXR Triage Pneumothorax | K213941 | 510(k) | Feb 24, 2022 |
Tempus AI Imaging Tempus AI | Tempus Pixel (applicant Arterys, Inc.) | K252539 | 510(k) | Sep 3, 2025 |
| Tempus AI Imaging | Arterys MICA (applicant Arterys, Inc.) | K203744 | 510(k) | Mar 14, 2022 |
| Tempus AI Imaging | Arterys MICA (applicant Arterys, Inc.) | K192437 | 510(k) | Mar 25, 2020 |
| Tempus AI Imaging | Arterys MICA (applicant Arterys, Inc.) | K182034 | 510(k) | Oct 17, 2018 |
| Tempus AI Imaging | Arterys Oncology DL (applicant Arterys, Inc.) | K173542 | 510(k) | Jan 25, 2018 |
| Tempus AI Imaging | Arterys Viewer (applicant Arterys, Inc.) | K171544 | 510(k) | Jul 18, 2017 |
| Tempus AI Imaging | Arterys Cardio DL (applicant Arterys, Inc.) | K163253 | 510(k) | Jan 5, 2017 |
| Tempus AI Imaging | Arterys Software v2.0 (applicant Arterys, Inc.) | K162513 | 510(k) | Oct 28, 2016 |
Hologic Genius AI Hologic | Genius AI Detection 2.0 | K243341 | 510(k) | Jul 31, 2025 |
| Hologic Genius AI | Genius Digital Diagnostics System with Genius Cervical AI algorithm | DEN210035 | De Novo | Jan 31, 2024 |
| Hologic Genius AI | Genius AI Detection 2.0 with CC-MLO Correlation | K230096 | 510(k) | May 23, 2023 |
| Hologic Genius AI | Genius AI Detection 2.0 | K221449 | 510(k) | Oct 6, 2022 |
| Hologic Genius AI | Genius AI Detection | K201019 | 510(k) | Nov 18, 2020 |
| HeartFlow Analysis | K250902 | 510(k) | Jul 18, 2025 | |
| HeartFlow | HeartFlow Analysis | K213857 | 510(k) | Oct 14, 2022 |
| HeartFlow | HeartFlow Analysis | K203329 | 510(k) | Jan 8, 2021 |
| HeartFlow | Not named in our record | K190925 | 510(k) | Aug 15, 2019 |
| HeartFlow | Not named in our record | K182035 | 510(k) | Dec 6, 2018 |
| HeartFlow | Not named in our record | K161772 | 510(k) | Aug 24, 2016 |
| HeartFlow | Not named in our record | K152733 | 510(k) | Jan 13, 2016 |
| HeartFlow | FFRct | DEN130045 | De Novo | Nov 26, 2014 |
| Viz Subdural+ | K250354 | 510(k) | Jun 10, 2025 | |
| Viz.ai | Viz HDS, Viz Volume Plus, Viz ICH+ | K232363 | 510(k) | Feb 5, 2024 |
| Viz.ai | Viz HCM | DEN230003 | De Novo | Aug 3, 2023 |
| Viz.ai | Viz AAA | K223443 | 510(k) | Mar 17, 2023 |
| Viz.ai | Viz LVO (ContaCT) | K223042 | 510(k) | Oct 21, 2022 |
| Viz.ai | Viz RV/LV | K221100 | 510(k) | Aug 29, 2022 |
| Viz.ai | Viz SDH | K220439 | 510(k) | Jul 25, 2022 |
| Viz.ai | Viz ANEURYSM | K213319 | 510(k) | Feb 18, 2022 |
| Viz.ai | Viz ICH | K210209 | 510(k) | Mar 23, 2021 |
| Viz.ai | Viz ICH | K193658 | 510(k) | Mar 18, 2020 |
| Viz.ai | Viz CTP | K180161 | 510(k) | Apr 20, 2018 |
| Viz.ai | ContaCT | DEN170073 | De Novo | Feb 13, 2018 |
GE HealthCare AI Suite GE HealthCare | Sonic DL | K243667 | 510(k) | Jun 5, 2025 |
| GE HealthCare AI Suite | Critical Care Suite | K223491 | 510(k) | May 25, 2023 |
| GE HealthCare AI Suite | AIR Recon DL | K213717 | 510(k) | Jun 8, 2022 |
Riverain ClearRead Riverain | ClearRead CT CAC | K242188 | 510(k) | Dec 3, 2024 |
| Riverain ClearRead | ClearRead CT | K221612 | 510(k) | Dec 5, 2022 |
| Riverain ClearRead | ClearRead Xray Pneumothorax | K213566 | 510(k) | Mar 10, 2022 |
| Riverain ClearRead | ClearRead CT | K161201 | 510(k) | Sep 9, 2016 |
| Riverain ClearRead | ClearRead +Confirm | K123526 | 510(k) | Dec 27, 2012 |
| Riverain ClearRead | DeltaView Model 2.1 | K111776 | 510(k) | Dec 28, 2011 |
| Riverain ClearRead | SoftView Model 2.01 | K092363 | 510(k) | Mar 18, 2010 |
| Riverain ClearRead | FirstView | K071492 | 510(k) | Aug 28, 2007 |
United Imaging uAI Shanghai United Imaging Intelligence | uAI Easy Triage ICH (Shanghai United Imaging Intelligence) | K242292 | 510(k) | Sep 24, 2024 |
| United Imaging uAI | uAI Portal (Shanghai United Imaging Intelligence) | K240411 | 510(k) | Sep 6, 2024 |
| United Imaging uAI | HYPER AiR (Shanghai United Imaging Healthcare) | K210001 | 510(k) | Apr 30, 2021 |
| United Imaging uAI | HYPER Focus (Shanghai United Imaging Healthcare) | K210418 | 510(k) | Apr 9, 2021 |
| United Imaging uAI | uAI EasyTriage-Rib (Shanghai United Imaging Intelligence) | K193271 | 510(k) | Jan 15, 2021 |
| United Imaging uAI | HYPER DLR (Shanghai United Imaging Healthcare) | K193210 | 510(k) | Aug 4, 2020 |
| United Imaging uAI | Deep Recon (Shanghai United Imaging Healthcare) | K193073 | 510(k) | Jul 6, 2020 |
| Rapid (6.0) | K233512 | 510(k) | Jan 16, 2024 | |
| RapidAI | Rapid | K213165 | 510(k) | Feb 8, 2022 |
| RapidAI | Rapid LVO | K200941 | 510(k) | Jul 9, 2020 |
| RapidAI | Rapid ASPECTS | K200760 | 510(k) | Jun 26, 2020 |
| RapidAI | Rapid ICH | K193087 | 510(k) | Mar 31, 2020 |
| RapidAI | iSchemaView RAPID | K182130 | 510(k) | Dec 27, 2018 |
| RapidAI | ISCHEMA VIEW RAPID | K121447 | 510(k) | Oct 4, 2013 |
MaxQ AI Accipio MaxQ AI | Accipiolx | K201310 | 510(k) | Aug 7, 2020 |
| MaxQ AI Accipio | Accipiolx | K182177 | 510(k) | Oct 26, 2018 |
| Red Dot | K191556 | 510(k) | Feb 28, 2020 |
Pathology
| Tool | Device on the FDA record | FDA number | Pathway | Decision |
|---|---|---|---|---|
Proscia Concentriq Proscia | Concentriq AP-Dx | K261380 | 510(k) | Aug 5, 2026 |
| Proscia Concentriq | Concentriq Dx (marketed as Concentriq AP-Dx) | K230839 | 510(k) | Feb 8, 2024 |
Indica Labs HALO AI Indica Labs | HALO AP Dx | K252762 | 510(k) | Nov 25, 2025 |
| Indica Labs HALO AI | HALO AP Dx | K232833 | 510(k) | May 7, 2024 |
PathAI AISight PathAI | AISight Dx | K243391 | 510(k) | Jun 26, 2025 |
| PathAI AISight | Novo | K212361 | 510(k) | Aug 11, 2022 |
Lumea BxChange Lumea | Viewer+ | K242244 | 510(k) | Mar 14, 2025 |
| Galen Second Read (Ibex Prostate Detect) | K241232 | 510(k) | Jan 24, 2025 | |
Tempus Digital Pathology Tempus AI | Paige FullFocus | K241273 | 510(k) | Jan 9, 2025 |
| Tempus Digital Pathology | Paige Prostate Detect | DEN200080 | De Novo | Sep 21, 2021 |
| Tempus Digital Pathology | Paige FullFocus | K201005 | 510(k) | Jul 15, 2020 |
Sectra Pathology Sectra | Sectra Digital Pathology Module (Version 3.3) | K232208 | 510(k) | Apr 16, 2024 |
| Sectra Pathology | Sectra Digital Pathology Module | K193054 | 510(k) | Mar 31, 2020 |
Surgical AI
| Tool | Device on the FDA record | FDA number | Pathway | Decision |
|---|---|---|---|---|
OTTAVA (J&J MedTech) J&J MedTech | OTTAVA Robotic Surgical System (applicant Auris Health, Inc.) | DEN250068 | De Novo | Jul 21, 2026 |
Asensus Surgical ISU KARL STORZ | Senhance Ultrasonic System | K254192 | 510(k) | May 12, 2026 |
| Asensus Surgical ISU | Senhance Surgical System | K233866 | 510(k) | Jul 19, 2024 |
| Asensus Surgical ISU | Senhance Surgical System | K223095 | 510(k) | Mar 16, 2023 |
| Asensus Surgical ISU | Senhance Surgical System | K220889 | 510(k) | May 27, 2022 |
| Asensus Surgical ISU | Senhance Surgical System | K212054 | 510(k) | Aug 30, 2021 |
| Asensus Surgical ISU | Senhance Surgical System | K211325 | 510(k) | Jul 27, 2021 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K202166 | 510(k) | Mar 2, 2021 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K200049 | 510(k) | Mar 9, 2020 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K192877 | 510(k) | Nov 22, 2019 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K191482 | 510(k) | Jul 11, 2019 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K183098 | 510(k) | Dec 6, 2018 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K181517 | 510(k) | Oct 9, 2018 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K180163 | 510(k) | May 25, 2018 |
| Asensus Surgical ISU | Senhance (TransEnterix) | K171120 | 510(k) | Oct 13, 2017 |
Activ Surgical ActivSight Activ Surgical | ActivSight Intraoperative Imaging System | K231344 | 510(k) | Aug 2, 2023 |
| Activ Surgical ActivSight | ActivSight Intraoperative Imaging System | K203550 | 510(k) | Apr 8, 2021 |
PrecisionOS PrecisionOS Technology | inVisionOS | K210344 | 510(k) | Nov 10, 2021 |
Updated October 20, 2026, from the catalog data behind each review. The FDA publishes its own list of AI-enabled devices; this index covers the tools we review and links every number to the FDA record. Spotted a missing clearance? Write to the corrections contact on the about page and we add it with its number. Cite this page as a dataset under CC BY 4.0.